Velcade (Bortezomib for Injection) Observational Study

Trial Information

Velcade (Bortezomib for Injection) Observational Study

This is a national, multi-center (study conducted in multiple sites), non-interventional (a scientific study where one or more investigators monitor one or more patients being treated with the same medication), observational study (a scientific study to make a clear and easy understanding of the cause and effect relationship) of Chinese Multiple Myeloma patients treated with Velcade. The study consists of 3 phases, including, screening phase, treatment phase, and follow up phase. In the screening phase, data will be collected on the basis of patient's demographic status, components of disease severity assessment, and potential prognostic factors. Data on prior cancer treatments will be collected retrospectively at baseline for patients receiving cancer treatment prior to receiving Velcade. In the treatment phase, Velcade is administered intravenously for a 2-week treatment period followed by a 10-day rest period. Each treatment cycle consists of 21 days. Prospective (in which the participants are first identified and then followed forward as time passes) observational data will be collected during treatment with Velcade. In the follow up phase, patients will be followed for up to three years to document long-term survival data. For patients who reinitiate Velcade, data collection should follow Velcade treatment period documentation process. Safety evaluations will be based on the incidence, intensity, and types of adverse events. The total duration of the study is set prospectively for three years from the date of the patients' initiation of Velcade.

Inclusion Criteria:

- Must give informed consent in agreement with local legislation

- Must not have any contraindication listed in package insert

Exclusion Criteria:

- Patients currently participating in another investigational study of Velcade or any other medication

- Patients with severe hepatic or renal impairment

- Patients with platelet count below 25000/μl

- Patients who are considered disqualified for the study by the investigators

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Information on treatment sequence for Velcade therapy

Outcome Description:

Treatment sequence or the line of therapy will be considered on Velcade utilization.

Outcome Time Frame:

Baseline (Day -1) to Day 21

Safety Issue:

No

Principal Investigator

Xian-Janssen Pharmaceutical Ltd., China Clinical Trial

Investigator Role:

Study Director

Investigator Affiliation:

Xian-Janssen Pharmaceutical Ltd.

Authority:

China: Ethics Committee

Study ID:

CR006373

NCT ID:

NCT01675245

Start Date:

March 2006

Completion Date:

May 2010

Related Keywords:

Multiple Myeloma

Multiple Myeloma

Cancer

Velcade

Bortezomib

Chinese patients

Multiple Myeloma

Neoplasms, Plasma Cell

Name

Location

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